Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

NCT00713427 | Completed Results DMC

• 2 other identifiers: ENDO-WALLFLEX-BIL-PALL-002E7020
• Study Type: interventional
• Target: 70
• Locations: 6 countries
• Sites: 6

Brief Summary

This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.

Conditions

Biliary Strictures Caused by Malignant Neoplasms

Keywords

Biliary; Strictures; Malignant; Neoplasm; Palliation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Absence of Recurrent Biliary Obstruction

  Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points.

  Up to 6 months post treatment or prior to death, whichever came first

Secondary Outcomes (6)

• Number of Adverse Events Related to the Device and/or Procedure

  From time participant signs informed consent until time participant exits study (up to 6 months following stent placement)

• Number of Participants With Technical Stent Placement Success

  Initial stent placement procedure

• Number of Participants With Occurrence of Re-intervention

  Up to 6 months post-initial study treatment

• Change in Biliary Obstruction Symptoms

  up to 6 months post-initial study treatment

• Time to Recurrent Biliary Obstruction

  Up to 6 months

Study Arms (1)

WallFlex Stent

OTHER

All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.

Device: WallFlex™ Biliary Partially-Covered Stent

Interventions

WallFlex™ Biliary Partially-Covered Stent DEVICE

Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.

WallFlex Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Inoperable extrahepatic biliary obstruction by any malignant process
• Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study

You may not qualify if:

• Participation in another invesitgational study within 90 days prior to date of patient consent.
• Strictures that cannot be dialated enough to pass the delivery system
• Perforation of any duct within the biliary tree
• Presence of any esophageal or duodenal stent
• Patients for whom endoscopic procedures are contraindicated
• Patients with known senesitivity to any components of the stent or delivery system
• Patients with active hepatitis

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (6)

ULB Erasme Hospital

Brussels, 1070, Belgium

Location

Hopital Edouard Herriot

Lyon, Cedex 3, 69437, France

Location

EVK Krankenhaus der Universitat Dusseldorf

Düsseldorf, D-40217, Germany

Location

Asian Institute of Gastroenterology

Hyderabaad, 500082, India

Location

Università Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Academisch Medisch Centrum Universiteit van Amsterdam

Amsterdam, AZ, 1105, Netherlands

Location

MeSH Terms

Conditions

Constriction, Pathologic; Neoplasms

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joyce Peetermans, PhD - Vice President, Global Clinical Programs
• Organization: Boston Scientific Corporation

Joyce.Peetermans@bsci.com

508-683-4211

Study Officials

• Robert Walsh, M.D.

  Boston Scientific Corporation

  STUDY DIRECTOR

• Guido Costamagna, M.D.

  Università Cattolica del Sacro Cuore, Policlinico A. Gemelli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 11, 2008
• Study Start: July 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 30, 2021
• Results First Posted: June 4, 2021

Record last verified: 2009-08

Locations

DE (1); BE (1); FR (1); IN (1); IT (1); NL (1)